N/A N=27 Randomized Other

UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT05178927 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process. — 2; 3; 3; 3 number of measurements

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HoloLens v2 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Florida
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process.	2; 3; 3; 3	—

Summary

The purpose of this study is to compare the accuracy, set-up time, and amount of image-guided radiotherapy (IGRT - a system that helps line up the radiation beam with the tumor for treatment) needed when mixed-reality guided radiotherapy is used for treatment set-up.

Eligibility Criteria

Inclusion Criteria

Targets adult patients who are planning to undergo photon or proton radiation therapy at UFHPTI for treatment of the breast or chest wall. As this type of treatment is rare in men, the study will focus on female patients only.

Exclusion Criteria

Male subjects

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Data sourced from ClinicalTrials.gov (NCT05178927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.